Location
Germantown, MD | United States
Job description
We're looking for an experienced leader to join our team! This individual will be r esponsible for regulatory compliance and accreditation, strategic planning, budgeting, quality assurance, provider relations, and creating an environment conducive to efficient daily operations. Responsible for scientific oversite of a modern CRO lab that develops and validates Ligand Binding Assays (LBA) and cell-based assays in support of biologic drug development and cell and gene therapy programs.
Essential Functions
- Establish the strategic goals and objectives, plan, staff, direct activities, and assure operational and financial effectiveness for the LMB (Large Molecule Bioanalysis) Laboratory.
- Responsible for direction and coordination of LMB personnel.
- Supervision of laboratory staff involved in complex drug development studies
- Creates and conducts quality assurance and control procedures for specimen processing.
- Identify the need for policy development and/or revision, defines policies in collaboration with higher level management input, goals and objectives.
- Client interaction in partnership with Business Development colleagues aimed at showcasing scientific expertise in order to win new business.
- Develop, monitors and revises functional processes.
- Maintain performance improvement activities within the department and participates in quality improvement activities.
- Ensure that laboratory is in compliance with regulatory and licensing agencies.
- Provide input into the development and revision of organizational structure for function or service for the LMB laboratory
- Create and conduct Quality Assurance and Quality Control activities to ensure laboratory instruments are properly maintained and functioning appropriately, quality control material is run as describe in the technical SOP, and that the control material is given the correct results:
- test reagents are functioning as expected;
- test results are accurate;
- testing methods are appropriate;
- specimen processing is done as describe in the protocols and;
- samples are stored and shipped as described in the protocol or in the protocol-specific lab manual.
Education and Experience
- PhD in a relevant field plus at least 7 years of GLP laboratory experience for biologic drug development
- Masters in relevant field plus at least 10 years related experience; OR Bachelors in relevant field with at least 15 years related experience.
- At least 7 years managing laboratory staff in a GLP or CLIA-certified clinical laboratory environment.
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